A Study of Ejaculatory Dysfunction in Men With Low Testosterone Levels

Condition(s) targeted: Ejaculatory Dysfunction; Hypogonadism

Intervention: Testosterone Solution 2% (Drug); Placebo Solution (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Eli Lilly and Company

Official(s) and/or principal investigator(s):
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Study Director, Affiliation: Eli Lilly and Company

The purpose of this study is to see if testosterone solution 2% can impact symptoms of ejaculatory dysfunction in men with low testosterone.

Official title: A Randomized, Double-Blind, Placebo-Controlled, Proof-of-Concept Study to Explore the Impact of Testosterone Solution 2% on Symptoms of Ejaculatory Dysfunction in Men With Testosterone Deficiency

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome: Change From Baseline in the Male Sexual Health Questionnaire-Ejaculatory Dysfunction-Short Form (MSHQ-EjD-SF) Ejaculatory Function Score at 16 Weeks

Secondary outcome:

Change From Baseline in Ejaculate Volume at 16 Weeks

Change From Baseline in Sexual Activity Log: Perceived Volume of Ejaculate at 16 Weeks

Change From Baseline in Sexual Activity Log: Perceived Force of Ejaculation at 16 Weeks

Change From Baseline in Sexual Activity Log: Delayed Ejaculation at 16 Weeks

Change From Baseline in Sexual Activity Log: Frequency of Sexual Attempts at 16 Weeks

Change From Baseline in Sexual Activity Log: Orgasmic Pleasure at 16 Weeks

Change From Baseline in the International Index of Erectile Function (IIEF)-Orgasmic Function Domain Score at 16 Weeks

Change From Baseline in MSHQ-EjD-SF Bother/Satisfaction Score at 16 Weeks

Minimum age: 26 Years. Maximum age: N/A. Gender(s): Male.

Criteria:

Inclusion Criteria:

- Total testosterone level <10. 4 nanomoles per liter (nmol/L) [300 nanograms per

deciliter (ng/dL)] at screening

- Presents with 1 or more of the following symptom(s) of ejaculatory dysfunction:

delayed ejaculation, anejaculation, decreased force of ejaculation, or decreased ejaculatory volume, as determined by investigator assessment

- Prostate-Specific Antigen (PSA) <4 nanograms per milliliter (ng/mL) at screening

Exclusion Criteria:

- Sexual partner who is or becomes pregnant at any time during the study

- Premature ejaculation as determined by investigator assessment

- Currently receiving testosterone replacement therapy or have a history of

insufficient response to testosterone replacement therapy for ejaculatory dysfunction symptoms

- Currently receiving treatment with cancer chemotherapy or antiandrogens

- History of use of estrogenizing agents

- Current use of warfarin

- History of selective serotonin reuptake inhibitor (SSRI) and/or

serotonin-norepinephrine reuptake inhibitor (SNRI) treatment in the 6 months prior to screening

- History of frequent opioid use within 30 days prior to screening, with exception of

treatment for chronic pain as determined by investigator.

- Body Mass Index (BMI) >35 kilograms per square meter (kg/m^2) at screening

- Significant peripheral neuropathy affecting erectile, ejaculatory, or orgasmic

function

- Hematocrit ≥50% at screening

- Exhibit systolic blood pressure >170 millimeters of mercury (mm Hg) or <90 mm Hg or

diastolic blood pressure >100 mm Hg or <50 mm Hg at screening (if stress is suspected, retest under basal conditions at screening), or have history of malignant hypertension

- History of any of the following coronary conditions within 90 days of screening:

myocardial infarction, coronary artery bypass graft surgery, percutaneous coronary intervention (for example, angioplasty or stent placement)

- Known or suspected carcinoma (or history of carcinoma) of the prostate or suspicious

nodules on digital rectal exam at screening

- Known or suspected breast cancer (or history of breast cancer) or other active cancer

(with the exception of nonmelanotic skin cancer)

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Los Angeles, California 90048, United States

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., San Diego, California 92120, United States

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., New Orleans, Louisiana 70112, United States

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Brookline, Massachusetts 02445, United States

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Great Neck, New York 11021, United States

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., New York, New York 10021, United States

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Quebec City, Quebec G1N 4V3, Canada

Starting date: August 2011
Last updated: December 12, 2014